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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K820278
Device Name INTRAVASCULAR ADMINISTRATION SET
Applicant
Y
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Y
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number880.5440
Classification Product Code
FPA  
Date Received02/02/1982
Decision Date 02/18/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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